Tag Archives for GSK

Top Ten DP Posts for 2010 (Nos. 4-2)

Two thousand ten brought the realization of Obama’s labors into the lives of all Americans. Suddenly all of the rhetoric and campaigning and mudslinging from all sides provided an air of tangibility with respect to the newly signed healthcare reform … Continue reading

29. December 2010 by Michael Douglas, MD, MBA
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Pharma Company Forges Partnership to Create Genetic Therapies for Rare Diseases

In an otherwise dull year for novel drug development, GSK is making positive news; it plans to expand into the realm of pharmaceutical development for the treatments of rare disorders. While this seems very noble for what it is, one … Continue reading

18. October 2010 by Michael Douglas, MD, MBA
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FDA: Keep Avandia on Market, Impose Ponderous Restrictions on Use

The FDA has announced today Avandia’s official indication. After months of teetering on the brink of availability many times over, GSK’s once star performer has now been relegated to last-ditch status. As of today, Avandia will be restricted to patients … Continue reading

23. September 2010 by Michael Douglas, MD, MBA
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FDA Tells Pharma Co. to Halt Recruitment for Its Own Safety Trial

Embattled pharma company GSK may be celebrating the continued availability of its once-blockbuster drug Avandia on the market, but it’s bemoaning the fact that the FDA is putting the breaks (halting recruitment) on a safety trial it has begun initiating … Continue reading

22. July 2010 by Michael Douglas, MD, MBA
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FDA: Avandia Stays on Market

The vote is 20-12 against withdrawing GSK’s troubled drug Avandia from the marketplace. Essentially, the FDA says that — in spite of the earlier vote the committee had on positively acknowledging the cardiac risks associated with the drug — those … Continue reading

14. July 2010 by Michael Douglas, MD, MBA
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FDA Discussions on Avandia Enter 2nd Day

As the debate over Avandia enters its second day, more controversy is sure to erupt. With both sides clinging to inexplicable minutiae as much as they are to the major points defining this hefty FDA review, the outcome will probably … Continue reading

14. July 2010 by Michael Douglas, MD, MBA
Categories: Corporate, Healthcare Policy & The Media, Knowledge & Medicine, Pharma & Devices, Politics & The Law, Science & Research | Tags: , , , , , , , , | Comments Off

Report: Pharma Company Covered Up Known Cardiovascular Risks of Drug

GSK (then known as SmithKline Beecham) knew in a 1999 trial that Avandia, the drug undergoing scrutiny on its fate in the pharma marketplace today, posed a signficant cardiac risk when compared to its major competitor Actos — and it … Continue reading

13. July 2010 by Michael Douglas, MD, MBA
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FDA to Decide Fate of Diabetes Drug This Week

It’s official. The FDA will convene this Tuesday (13) to discuss and come to a decision on the fate of GSK’s Avandia. I guess you could literally call this agent a wonder drug — as its continued availability in the … Continue reading

11. July 2010 by Michael Douglas, MD, MBA
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Diabetes Drug Once Again under Scrutiny

A couple of weeks before the FDA meets to discuss the safety of the antidiabetic medication Avandia come (coincidentally) more reasons this agent should be withdrawn from the pharma marketplace. One study concludes that Avandia increased the risk of death, … Continue reading

29. June 2010 by Michael Douglas, MD, MBA
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Report: Pharma Amplified Global H1N1 Scare

What is known about the H1N1 epidemic that plagued the world in 2009 was its influence in global approach to this infection — for good or bad — and the costs to nations which chose to meet its threat head … Continue reading

04. June 2010 by Michael Douglas, MD, MBA
Categories: Politics & The Law, Science & Research | Tags: , , , , , , , | 1 comment

FDA Considers Ending Troubled GSK Drug’s Involvement in Safety Study

Add yet another blow to GSK’s once-blockbuster diabetes drug, Avandia (rosiglitazone). The ongoing soap opera that is this drug’s manufacture and continued presence begins another chapter in its struggle to retain some semblance of competition in the pharma marketplace. Avandia’s … Continue reading

19. April 2010 by Michael Douglas, MD, MBA
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Pharma Company Goes on the Defensive Amid New Avandia Attacks

A safety review of GSK’s Avandia, under fire and intense scrutiny for its role in the possible development of cardiac adverse effects is nearing completion. In spite of the continued negative press, the pharma company has issued a thirty page … Continue reading

26. February 2010 by Michael Douglas, MD, MBA
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Two Major Pharma Companies Announce Joint Venture

Glaxo (GSK) and Pfizer aim to create a new HIV drug company. Both drugs have a financial stake in the matter as both entities’ current products are essentially devoid of further innovation. GSK’s lack of new product (it’s already the … Continue reading

19. April 2009 by Michael Douglas, MD, MBA
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